“Biosimilars Series - Regulatory And Development Issues” finds that while five biosimilar products have already been approved in Europe, the US still needs key legal clearance before it can gain approval from the Food and Drug Administration (FDA).
The report says skyrocketing healthcare costs and expenditure on biologics have encouraged U.S lawmakers to propose three different bills this year alone formulating a statutory pathway for the approval of biosimilars. Industry analysts, however remain doubtful about whether legislation will be passed by the end of this year which would pave the way for clearance on biosimilars from the FDA.
Biosimilars are also called biogenerics, follow-on proteins or follow-on biologics in the U. S. They are generic versions of biotechnology products. The study points out that since biosimilars are made in living organisms and manufacturing processes are trade secrets, generic versions of biologics cannot be kept identical to their reference products. In this regard, they are not true generics and need to get treated differently from generics of small molecule drugs.
Europe adopted a new directive in 2004 outlining the legal area for the approval of biosimilars. Even though the law itself is very basic, its main goal was to endow the European Medicine Evaluation Agency (EMEA) authority to approve biosimilars based on their scientific guidelines and requirement.
Industry analysts say political issues and the uneasy relationship between innovators and generic companies have delayed formulation of key U. S legislation pertaining to the regulatory approval of biosimilars. They also point out that U.S legislation is much more detailed than the EC directive as it addresses issues such as market exclusivity and patent litigation. It also proposes that the FDA is given freedom on setting requirements to approve biosimilars. The report says the FDA is widely expected to be led by EMEA’s precedents in the matter.
Authors of the report analyses the possible impacts of important bills becoming laws in the U.S. They take into account the effect the benefits of potential one-year exclusivity the first biosimilar producer can receive and its influence on the commercial success of biosimilars. The study also looks at the legal framework allowing the creation of a highly litigious environment which could deter smaller players and result in lowering the possibility of price discounts in the market.
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